Senior Regulatory Manager, Quality
hace 7 días
Overview Fullscript is a healthcare platform that delivers high‑quality supplements, industry‑leading lab testing, and tools to help practitioners provide personalized, efficient, and effective care. Responsibilities Lead and mentor the Regulatory team, fostering a culture of ownership, accountability, and professional growth. Oversee regulatory operations and readiness for audits and inspections across FDA, FTC, Health Canada, CFIA, CLIA, and other authorities. Manage and maintain regulatory registrations, facility licensing, and supplier qualifications. Partner with internal teams to confirm product labeling and marketing claims across supplements, cosmetics, foods, and diagnostics. Collaborate on complaint handling, recalls, and corrective actions in partnership with Distribution, Finance, Customer Experience, and Brand teams. Work cross‑functionally with Legal, Quality, and Distribution to proactively anticipate regulatory changes and strengthen processes to ensure ongoing improvement and alignment across SOPs and documentation. Provide regulatory oversight for diagnostic laboratories and self‑collection testing kits, ensuring compliance with CLIA and related regulations. Monitor and report on key regulatory KPIs, providing performance insights and recommendations to leadership. Qualifications 10+ years of regulatory compliance experience, including 5+ years in a management role overseeing regulatory professionals. Deep working knowledge of U.S. and Canadian regulations specific to dietary supplements, foods, cosmetics, diagnostics, OTCs, and medical devices. Strong familiarity with FDA, Health Canada, CFIA, CLIA, FTC, and Prop 65 regulations. Proven ability to lead regulatory strategy, manage audits, and make informed decisions in high‑stakes situations. Bachelor's degree in a life sciences field (e.g., Food Science, Biology, Biochemistry, Clinical Laboratory Science); advanced degree preferred. Exceptional leadership and communication skills, with the ability to manage and influence cross‑functional stakeholders effectively. Bonus: translating complex regulatory requirements into clear guidance for non‑technical stakeholders; implementing or optimizing regulatory software systems or digital quality management tools; navigating ambiguity in evolving regulatory environments; supplier or contract manufacturer auditing background. Benefits & Perks Market‑competitive compensation package including equity. 401(k) matching (within US) / RRSP matching (within CAD). Flexible PTO policy. Employee discount on Fullscript catalog of products for family & friends. Ability to work wherever you work best. Team values: innovation, growth, and work‑life balance. How to Apply Apply directly through our careers page. Due to high volume of interest, we are not able to respond to individual emails or messages about job postings. If your background aligns with what we’re looking for, a member of our team will reach out to you directly. Equal Opportunity Fullscript is an equal‑opportunity employer committed to creating an inclusive workplace. Accommodations are available upon request—please email **** for support. Before joining the team, all candidates who receive and accept an offer will complete a background check. We use AI tools to support parts of our hiring process, like screening and reviewing responses. Final decisions are always made by people. This process complies with privacy and employment laws across Canada and the U.S. #J-18808-Ljbffr
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